advanced squamous cell lung cancer with idiopathic interstitial pneumonia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Squamous cell lung cancer 2) Age over twenty 3) Idiopathic interstitial pneumonia 4) Measurable lesion 5) ECOG performance status 0 or 1 6) Adequate organ function WBC>=3000/mm3 and neutrophil count >=2000/mm3 Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL 7) PaO2>=60.0 torr or SpO2>=92.0 %( room air) 8) No symptoms from brain metastasis 9) Life expectancy > 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Secondly interstitial pneumonia. 2) History of acute exacerbation of interstitial pneumonia within 3 months. 3) Subacute progression of interstitial pneumonia within 3 months. 4) Using prednisolone or immune-suppressive agent. 5) Need to home oxygen therapy. 6) Past history of severe drug allergy. 7) Active infectious disease. 8) Severe complications 9) Symptomatic brain metastasis. 10) Uncontrollable effusion. 11) Active combined malignancy 12) Any ineligible case judged by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| OS: overall survival PFS: progression free survival TTF: Time to treatment failure toxicity | — |
Countries
Japan
Contacts
Osaka Preferctural Medical Center for Respiratory and Allegic Diseases Thoracic Oncology